EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Study information

Scientific title

Acronym

UKALL 14

Study hypothesis

1.1. 1B (precursor-B lineage): to determine if the addition of rituximab to standard induction chemotherapy results in improved event-free survival (EFS) in patients with precursor B-cell lineage acute lymphoblastic leukaemia (ALL)1.2. 1T (T lineage): to determine if the addition of nelarabine following standard induction therapy (arms T1 and T2) improves outcome for patients with T cell ALL2. To determine the tolerability of Pegylated asparaginase in induction (for all patients) and to compare anti-asparaginase antibody levels between patients in the 2 randomisation groups from aim 1B3. To determine whether risk-adapted introduction of unrelated donor HSCT (myeloablative conditioning in patients aged up to and including 40 years at time of study entry and non-myeloablative conditioning in patients aged greater than 40 years, i.e., having reached their 41st birthday at time of study entry) result in greater EFS for patients at highest risk of relapse4. To compare 2 schedules of administration (standard P1 versus 'collapsed' P2) of keratinocyte growth factor (palifermin) for efficacy in preventing the severe mucosal toxicity of etoposide/TBI HSCT conditioning regimen

Ethics approval

West London REC 2, 13/01/2010, ref: 09/H0711/90

Study design

Randomised interventional treatment trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Intervention

Rituximab: To determine if the addition of monoclonal antibody to standard induction chemotherapy results in improved EFS in patients with precursor B-cell lineage ALLNelarabine: To determine if the addition of nelarabine following standard induction therapy (arms T 1 and T2) improves outcome for patients with T cell ALLOncaspar: To determine the tolerability of pegylated asparaginase in induction (for all patients) and to compare anti-asparaginase

1. Rituximab: 375 mg/m2 given by IV on days 3, 10, 17 and 24 of Phase 1 induction therapy2. Oncaspar: 1000 IU/m2 given by IV on days 4 and 18 of Phase 1 induction therapy3. Nelarabine: 1.5 g/m2 given by IV on days 1, 3 and 5 immediately following Phase 2 induction therapy4. Palifermin: 60 ug/kg given either on days -10, -9, -8, 0, 2 and 4 or -9, 0, 2 and 4 of myeloablative conditioning regimen

Total duration of treatment is approximately 2 years 6 months for all patients who complete treatment. Patients are followed up until death.

Intervention type

Other

Phase

Phase III

Drug names

Primary outcome measure

1. Event free survival (applies to all interventions), measured from date of randomisation until the date of relapse2. Toxicity related to pegylated asparaginase, measured after Phase 1 induction therapy

Secondary outcome measures

1. Anti-asparaginase antibodies (induction randomisation only), measured at the end of Phase 1 induction therapy2. Overall survival, measured from date of randomisation until date of death3. Complete remission rate: % of patients in complete remission at the end of Phase 2 induction therapy

Overall trial start date

01/06/2008

Overall trial end date

31/12/2023

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Subjects must be aged greater than or equal to 25 and less than or equal to 65 years old with acute lymphoblastic leukaemia, either sex2. Newly diagnosed, previously untreated ALL (a steroid pre-phase of 5 - 7 days is acceptable and can be started prior to registration)3. Written informed consent

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

IPD sharing statement:The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

31/12/2024

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

07/08/2018: The following changes were made to the trial record:
1. The target number of participants was changed from "Planned sample size: 720; UK sample size: 720" to "Planned sample size: 811; UK sample size: 811"
2. The total target enrolment was changed from 720 to 811
3. The recruitment end date was changed from 30/06/2018 to 26/07/2018
12/02/2018: The following changes were made:
1. Overall trial start date was changed from 01/12/2010 to 01/06/2008.
2. Recruitment start date was changed from 01/12/2010 to 30/12/2010.
3. Recruitment end date was changed from 31/12/2016 to 30/06/2018.
4. Overall trial end date was changed from 31/12/2016 to 31/12/2023.
5. Publication and dissemination plan, intention to publish date and participant level data were added.